SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
FDA Recall Z-0877-2020 · Posted 2020-01-28
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2019-12-23
Date Terminated2020-12-11
Product Quantity62 (30 US, 32 OUS) total devices
Reason for Recall
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
Firm Action
This issue will be resolved by sending an Urgent Medical Device Correction letter to Medical Facility staff (Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering) with affected systems. This letter will inform the customer of the issue and instruct the user to ensure the displayed system date is correct. The long-term solution is to correct affected systems with updated software.
Root Cause
Software design
Distribution Pattern
Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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